Method of fixing a suture to tissue

ABSTRACT

A method of fixing a suture to tissue of a patient includes placing an introducer onto a finger, the introducer including a zip line trailing from a proximal end of the introducer. The method additionally includes identifying a landmark with the finger, guiding a delivery device along the zip line toward the introducer, where the delivery device maintaining an anchor attached to a suture line, and ejecting the anchor from the delivery device and into the tissue of the patient.

BACKGROUND

Intracorporeal suturing of tissue during surgery presents challenges tothe surgeon in that the surgeon is called upon to manipulate one or moresuturing instruments within the confines of an incision formed in thepatient's body. In some cases, the surgeon will use his/her finger(s) todissect tissue or separate tissue along tissue planes to form a spacewithin the tissue that allows the surgeon to palpate and identify adesired target location for placement of a suture. Often, the spaceformed in the dissected tissue is opened until it is large enough toreceive both the surgeon's finger(s) and the suturing instrument(s). Thespace provides access to the identified target location where it isdesired to place the suture. However, the target location is oftendisposed inside the patient's body at an angle that is difficult toreach and can have a depth that precludes visualization of the targetlocation. Delivering surgical instruments to the target location ischallenging when the target location cannot be visualized by thesurgeon.

SUMMARY

One aspect provides a method of fixing a suture to tissue of a patient.The method includes placing an introducer onto a finger, the introducerincluding a zip line trailing from a proximal end of the introducer. Themethod additionally includes identifying a landmark with the finger,guiding a delivery device along the zip line toward the introducer,where the delivery device maintaining an anchor attached to a sutureline, and ejecting the anchor from the delivery device and into thetissue of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is an exploded schematic view of one embodiment of a digitalsuture fixation system including an introducer and an anchor deliverydevice.

FIG. 2 is a bottom view of the introducer illustrated in FIG. 1.

FIG. 3 is a top view of the delivery device illustrated in FIG. 1.

FIG. 4 is a cross-sectional view of the delivery device illustrated inFIG. 3.

FIG. 5 is an end of view of the delivery device illustrated in FIG. 3.

FIG. 6A is a side view of a finger wearing the introducer illustrated inFIG. 1.

FIG. 6B is a side view of the delivery device illustrated in FIG. 3shuttled along a zip line to the introducer illustrated in FIGS. 1 and2.

FIG. 6C is a side view of the system illustrated in FIG. 1 employed todeliver an anchor to tissue of a patient according to one embodiment.

FIG. 6D is a schematic view of a suture line trailing away from theanchor that has been fixed into the tissue of the patient.

FIG. 7 is an exploded perspective view of a digital suture fixationsystem including an introducer and an anchor delivery device accordingto one embodiment.

FIG. 8A is an exploded side view of the system illustrated in FIG. 7.

FIG. 8B is a schematic exploded view of a cable engaging with an anchorassembly of the system illustrated in FIG. 8A according to oneembodiment.

FIG. 9A is a side view of a finger wearing the system illustrated inFIG. 7.

FIG. 9B is a side view of the delivery device illustrated in FIG. 7delivered to a landmark inside of the patient's body.

FIG. 9C is a side view of the system illustrated in FIG. 7 employed todeliver an anchor to the landmark inside of the patient's body.

FIG. 9D is a side schematic view of a telescoping anchor housing.

FIG. 10 is a perspective view of an optional position marker configuredto be employed with the system illustrated in FIG. 7 according to oneembodiment.

FIG. 11 is a side plan view of a digital suture fixation systemincluding a delivery device attached to an introducer band according toone embodiment.

FIGS. 12A-12C are schematic cross-sectional views of the digital suturefixation system illustrated in FIG. 11 employed to throw a needlethrough tissue according to one embodiment.

FIG. 13 is a perspective view of the introducer band illustrated in FIG.11.

FIG. 14 is a perspective view of another embodiment of an introducerband.

FIG. 15 is a perspective view of another embodiment of an introducerband attached to the delivery device illustrated in FIG. 11.

FIG. 16 is a perspective view of another embodiment of an introducerband attached to the delivery device illustrated in FIG. 11.

FIG. 17 is a perspective view of another embodiment of an introducerband attached to the delivery device illustrated in FIG. 11.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

A digital suture fixation system is a system that allows suture line tobe thrown through tissue and/or allows the placement of an anchor intothe tissue with a hand or one or more fingers on the hand. A digitalsuture fixation system allows for the “finger tack” fixation of sutureline and/or anchors into the tissue.

Embodiments provide a finger guided suture fixation system that includesan introducer that is configured to be donned over a finger of a surgeonto allow the finger to palpate and identify a landmark within thepatient, and a delivery device configured to insert an anchor at theidentified landmark. As an example, the introducer is provided with azip line that is sized to trail proximally behind the finger to alocation outside of the patient's body. The delivery device is movablealong the zip line and attachable to the introducer. In this manner, thesurgeon is able to locate a target site of interest with his/her fingerand pass the delivery device along the zip line to the finger until itis placed at or near the target site to allow the precise placement ofthe anchor even without visually seeing the target site.

In this specification, “zip line” means a conduit, such as a cable, thatprovides a pathway from a location exterior a patient's body to alocation intracorporeal the patient's body.

FIG. 1 is a side view of one embodiment of a digital suture fixationsystem 150. System 150 includes an introducer 152 that is attachable toa finger F, a delivery device 154 that is attachable to introducer 152,and an anchor 156 that is removably retained in the delivery device 154.

In one embodiment, introducer 152 includes a finger cot 160, a platform162 attached to an exterior surface of finger cot 160, and a zip line164 attached to platform 162. In one embodiment, delivery device 154includes a car 170 configured to couple with and move along the zip line164 and a shaft 174 that is configured to eject anchor 156 from car 170.The car 170 defines a port 172 sized to enclose anchor 156. In oneembodiment, anchor 156 includes a barb portion 180 configured to engagewith tissue and a suture line 182 trailing from barb portion 180. In oneembodiment, the shaft 174 includes a distal end 190 that is attachableto the car 170, a proximal end 192 including a plunger 194, and a rod196 that moves into and out of the shaft 174 in response to movement ofthe plunger 194.

System 150 is adapted to deliver anchor 156 to a landmark within thepatient, where the landmark is not necessarily visible to the surgeon.For example, the finger cot 160 allows the finger F to identify thedesired landmark, the car 170 is attachable to the platform 162 (whichis located near a distal end of the finger F) to ensure that the anchor156 is directed to the landmark identified by the finger F, and theshaft 174 is employed to selectively eject the anchor 156 into thelandmark. Although the landmark in FIG. 1 is illustrated as a ligament,system 150 is configured to allow the surgeon to palpate and identifyany of a variety of intracorporeal landmarks.

The systems disclosed in this specification are suited for theintracorporeal suturing of tissue during pelvic organ repair surgery,and in one embodiment are provided as sterile disposable surgicalinstruments that are discarded after the surgical procedure. To thisend, the components of the systems are selected to be compatible withgas, steam, or radiation sterilization.

FIG. 2 is a bottom view of introducer 152 showing zip line 164 trailingfrom a proximal end of introducer 152. In one embodiment, introducer 152includes a window 200 formed in the finger cot 160 between platform. 162and a distal end of the finger cot 160. In one embodiment, the window200 allows the finger F to directly contact tissue within a patient. Inone embodiment, the window 200 allows a finger F inside of a glove (notshown) to identify a tissue landmark within a patient, where the gloveis selected to provide the surgeon with a level of dexterity suited tosensing and discriminating different intracorporeal tissue landmarks.The platform 162 includes a retainer 204 that is configured to engagewith the car 170 (FIG. 1) to secure the car 170 to the introducer 152.In one embodiment, the retainer 204 is provided as a pair of opposingsubstantially spherical recesses that are sized to receive spring-loadedball bearings provided on the car 170.

Finger cot 160 is selected to be conformable to a distal end of thefinger F, suitably elastic, and is suitably fabricated from plastic,metal, or combinations of plastic and metal (e.g., malleable metalthimbles covered with plastic as one example). Platform 162 is attachedto finger cot 160 and is suitably formed from plastic, metal, orcombinations of plastic and metal. Suitable suture line 182 materialsinclude suture employed by surgeons in the treatment of pelvic organprolapse, such as polypropylene suture, or the suture identified asDeklene, Deknatel brand suture, as available from Teleflex Medical,Mansfield, Mass., or suture available from Ethicon, a Johnson&JohnsonCompany, located in Somerville, N.J.

The zip line 164 is flexible and is suitably fabricated from a polymerstrand, or a braided cable coated with plastic, as examples.

In one embodiment, introducer 152 is integrated into a distal fingersleeve of a glove, which allows the introducer 152 to be more closelyassociated with the surgeon's hand.

FIG. 3 is a top view of car 170, FIG. 4 is a cross-sectional view of car170, and FIG. 5 is a proximal end view of car 170. In one embodiment,car 170 includes a proximal end 210 opposite a distal end 212, aplatform dock 214 formed adjacent to distal end 212, a zip line channel216 extending between end 210 and dock 214, and a suture channel 218extending between end 210 and port 172. The platform dock 214 includes alock 220 configured to couple with retainer 204 to secure car 170 toplatform 162 (FIG. 2). In one embodiment, the lock 220 includesspring-loaded ball bearings or another form of a biasing memberconfigured to engage with recesses 204 formed on platform 162. The car170 is configured to slide along the zip line 164 until lock 220 engageswith retainer 204 to secure the car 170 to the platform 162.

In one embodiment, threads 222 are formed within a proximal end ofsuture line channel 218 and are sized to receive a threaded distal end190 of shaft 174 (FIG. 1). In this manner, shaft 174 is configured to beremovably attached to the car 170 such that rod 196 (FIG. 1) is alignedwith suture line channel 218 and the barb portion 180 of anchor 156.

FIG. 5 is a proximal end view of car 170. In one embodiment, car 170 issubstantially a circular cylinder, although other shapes and sizes thataccommodate the intracorporeal delivery of the car 170 into the patient,as guided by the surgeon's preferences, are also acceptable.

FIGS. 6A-6D are side views of system 150 employed to insert an anchorinto tissue according to one embodiment.

FIG. 6A is a side view of introducer 152 placed over the finger F suchthat the finger F is available to palpate tissue through the window 200.

FIG. 6B is a side view of car 170 and shaft 174 of delivery device 154moving along a zip line 164 for engagement with platform 162. It is tobe understood that shaft 174 could be suitably attached to car 170before car 170 is engaged with the zip line 164 or after the car 170 isengaged with the zip line 164.

FIG. 6C is a side view of the car 170 engaged with the platform 162 andthe shaft 174 connected to the car 170. In one embodiment, the barbportion 180 of the anchor 156 is retained within port 172 (FIG. 1) andsuture line 182 trails from the proximal end 210 of the car 170 (FIG.4). In this configuration, the shaft 174 is connected to the car 170,and the car 170 is connected to the platform 162, where the platform 162and the car 170 are positioned adjacent to the window 200 and thus readyto deliver the barb portion 180 into the tissue (e.g., ligament)palpated by the finger F. In one embodiment, the surgeon uses theopposite hand (e.g., the hand to which introducer 152 is not attached)to activate the plunger 194, which drives the rod 196 (FIG. 1) axiallyfrom the shaft 174 to eject the barb portion 180 of the anchor 156axially from the car 170 and into the ligament, as illustrated in FIG.6D. Although the plunger 194 is illustrated as a push-activatedmechanical device in FIG. 6C, other embodiments of the plunger 194provide a plunger that operates pneumatically or electro-mechanically.Other suitable activation mechanisms for moving rod 196 to deliveranchor 156 include pull activation, twist activation, or squeezeactivation of shaft 174 to activate movement of rod 196.

The anchor 156 is configured to penetrate tissue, including toughligament tissue, and engage with the tissue after penetration. In oneembodiment, the barb portion 180 is selectively deployed to expand fromthe anchor 156 only after the anchor penetrates into the tissue. In oneembodiment, the barb portion 180 extends laterally from the anchor 156and engages with the tissue as soon and the anchor penetrates into thetissue.

FIG. 7 is a perspective view of another embodiment of a digital suturefixation system 250. In one embodiment, system 250 includes anintroducer 252 that is attachable to a finger, a delivery device 254attached to introducer 252, and an anchor (not shown) that is removablyattachable to delivery device 254. In one embodiment, the introducer 252is a band 252 that is attachable to the finger and the delivery device254 and includes an anchor housing 256 attached to an exterior surfaceof the band 252. The delivery device 254 includes a shaft 258 having adistal end 260 that is configured to thread into a proximal end of theanchor housing 256. The anchor housing 256 is sized to retain an anchor(or an anchor and a suture line) and the shaft 258 is configured todeploy the anchor from the anchor housing 256.

FIG. 8A is a side view of system 250. The anchor housing 256 includes achannel 270 that is sized to receive anchor 156 and suture line 182. Inone embodiment, anchor housing 256 has a longitudinal length betweenabout 0.75-1.5 inches, and band 252 is configured to allow housing 256to slide/move longitudinally (laterally left and right in theorientation of FIG. 8A). In this manner, the anchor housing 256 is sizedto be positioned at a base segment of the finger (behind the distal-mostjoint of the finger) to allow the distal end of the finger freedom ofmovement. The anchor housing 256 is configured to move relative to theband 252 to a position adjacent to the distal end of the finger F tobring the anchor 156 near the desired landmark previously identified bythe surgeon's finger F.

In one embodiment, the band 252 is provided as adjustable band includinga buckle or other adjustable form of attachment. Suitable materials forfabrication of the band 252 include plastics, metals, or combinations ofplastics and metals. In one embodiment, the anchor housing 256 is moldedfrom plastic attached to the band 252. In one embodiment, shaft 258 issimilar to shaft 174 (FIG. 1).

FIG. 8B is an exploded schematic view of shaft 258 moved distallyforward and ready for engagement with anchor 156. In one embodiment,shaft 258 includes an extensible post 272 that is configured to extendout of a distal end 260 of shaft 258 to engage with a bore 274 formed inanchor 156. In this manner, the post 272 is configured to drive theanchor 156 axially out of the channel 270 and into the tissue of thepatient.

FIGS. 9A-9C provides schematic views of system 250 employed to deliveran anchor into tissue.

FIG. 9A is a schematic view of the band 252 attached to the finger F ina manner that locates the anchor housing 256 at the base of the finger Fnear the web of the thumb. The distal end of the finger F is unimpededby the anchor housing 256 and is thus free to palpate the tissue. Theshaft 258 trails behind the anchor housing 256 out of the patient's bodyfor access by the other hand (e.g., the right hand in this example).

The finger F is fully mobile (even if protected by a surgical glove) andable to palpate a desired tissue location for deployment of anchor 156.As illustrated in FIG. 9B, the anchor housing 256 is movable relative tothe band 252 to position the distal end of the anchor housing 256(retaining the anchor 156) next to the tissue landmark. In oneembodiment, the shaft 258 is pushed in a proximal direction to displacethe housing 256 proximally forward toward the tissue.

The anchor housing 256 is not drawn to scale. In one embodiment, it isdesirable to provide the anchor housing 256 in a low-profile format(e.g. a flat elliptical shape) that is configured to lay flat againstthe palm of a user's hand. For example, in one embodiment the anchorhousing 256 has a lateral cross-sectional size that is similar to thesize of the diameter of the shaft 258 such that the shaft 258 and thehousing 256 appear as a single cable.

FIG. 9C illustrates anchor 156 driven into the tissue by the post 272(FIG. 8B) of the shaft 258. The suture line 182 is optional, and ifprovided, trails behind the anchor 156 through the anchor housing 256and behind the hand of the surgeon. In one embodiment, the shaft 258 isrotated counterclockwise (one-quarter to one-half of a turn) todisengage the shaft 258 from the anchor 156. Thereafter, the surgeonretracts the finger F and the system 250 from the patient leaving theanchor 156 inserted into tissue and the suture line 182 trailing awayfrom the anchor and out of the patient. The suture line 182 is tied offto reinforce or suture the pelvic floor of the patient. Alternatively,the suture line 182 serves as a conduit into the patient's body fordelivery of support mesh intracorporeally to the inserted anchor 156.

FIG. 9D is a side schematic view of a telescoping anchor housing 256′.The telescoping anchor housing 256′ has a proximal end 280 that nestlesagainst a web of the hand and a distal end 282 that moves forward towardthe distal end of the finger F when the shaft 258 is pressed into theproximal end 280 of the anchor housing 256′. The proximal end 280contacts the webbing of the hand to allow the hand to drive the distalend 282 forcefully into the tissue to ensure that the anchor 156penetrates tough tissue. Consistent with the above description,activation of the shaft 258 moves the post 272 in the axial forwarddirection to eject the anchor 156. In one embodiment, shaft 258 isattached to the proximal end 280 of the delivery device 256′, the shaft258 is pushed distally, and separating segments of the telescopingdelivery device 256′ axially expand to drive anchor 180 into the tissue.

FIG. 10 is a perspective view of an optional position marker 290configured for use with system 250. In one embodiment, position marker290 includes a distal surface 292, a proximal surface 294, a slot 296formed between the surfaces 292, 294, and a hole 298 formed in theproximal surface 294. In one embodiment, position marker 290 is providedas a stroke-length control and twist-release locator that is configuredto be tacked into position by the anchor 156. For example, in oneembodiment the hole 298 is sized to receive the distal end of anchorhousing 256 (FIG. 8A) to allow accurate placement of the anchor 156 intothe tissue. The position marker 290 functions to prevent inserting theanchor 156 too deeply into the tissue. The position marker 290 alsofunctions to prevent twisting of the anchor 156 after placement of theanchor 156 to tissue. In one embodiment, position marker 290 includesanother suture line 300 that is configured to trail out of the patient'sbody to a location that can be accessed by the surgeon for thesubsequent delivery of support mesh into the patient to the location atwhich position marker 290 has been affixed.

Suitable materials for fabrication of position marker 290 includeplastic or radio-opaque material.

FIG. 11 is a side plan view of a digital suture fixation system 350including an introducer band 352 that allows the surgeon to use a fingerto precisely place a delivery device 354 next to a tissue landmark. Theintroducer band 352 is attachable to the finger F and a suture assembly356 is retained by a head 364 of the delivery device 354. Thisconfiguration allows the finger F to guide the head 364 of the deliverydevice 354 directly and precisely to an intracorporeal tissue landmark(i.e., a target) identified by the finger F. The surgeon inserts his/herfinger into the band 352 to guide the delivery device 354 through thedissected tissue precisely to the landmark previously identified by thefinger, which positions the head 364 for delivery of the suture assembly356 to the tissue landmark.

Delivery device 354 includes a shaft 360 coupled between a handle 362and the delivery head 364. The introducer band 352 is attachable to thehead 364. Handle 362 thus defines a proximal end of system 350 nearest auser of the system 350.

With reference to FIGS. 11 and 12A, the needle 374 is stored within aproximal end portion 376 of the head 364 and the suture assembly 356 isstored within a distal end portion 378 of the head 364. The open spacebetween the proximal end portion 376 of the head 364 and the distal endportion 378 of the head 364 is referred to as a throat. In oneembodiment, the suture assembly 356 includes a suture line 380 connectedto a capsule 382, and the capsule 382 is retained within distal end 378of head 364. The needle 374 is adapted to move across the throat fromthe proximal end portion 376 of the head 364 to the distal end portion378 of the head 364. The needle 374 is shaped to frictionally engage andmate with the capsule 382, remove the capsule 382 from distal end 378,and retract the capsule 382 into the proximal end portion 376 of head364. In this manner, the suture line 380 is towed behind the capsule 382and “thrown” through the tissue.

For example, handle 362 includes an actuator 370 communicating with arod 372 that is disposed within shaft 360. The throat formed in the head364 is configured to be engaged over a mass of tissue. When actuator 370is activated (for example with the surgeon's free hand exterior to thepatient), the rod 372 moves through shaft 360 to extend the needle 374stored within the proximal end portion 376 of head 364 axially outwardthrough tissue and toward the distal end 378 of head 364. Thus, theneedle 374 moves away from the user (who is holding handle 362 at theproximal end of system 350) and is thrust through the tissue towarddistal end 378 of system 350. The needle 374 ultimately grasps thecapsule 382, and the needle 374 and the capsule 382 are pulled backthrough the channel formed in the tissue by the needle 374. Retractionof the needle 374 pulls the suture line 380 through the tissue, to“throw” the suture line through the tissue.

FIGS. 12A-12C are schematic cross-sectional views of digital suturefixation system 350 employed to throw needle 374 and capsule 382/suture380 through tissue.

FIG. 12A is a schematic cross-sectional view of needle 374 partiallyextending from the proximal end portion 376 of head 364 after activationof actuator 370 (FIG. 11). Capsule 382 is seated in a cavity formed inthe distal end 378 of head 364. It is recommended that the surgeondirect a trailing end of suture 380 over distal end 378 of head 364 andback toward a proximal end of shaft 360 (FIG. 11) for ease of managingthe suture assembly during the procedure. To this end, in one embodimentthe handle 362 is provided with a reel configured to receive the suture380. For example, in one embodiment the suture 380 is retained on asuture cartridge, and the handle 362 is provided with a spindleconfigured to receive and retain the suture cartridge.

FIG. 12B is a schematic cross-sectional view of head 364 illustratingthe needle 374 moved across the throat of head 364 and engaged withcapsule 382. It is to be understood that the throat would typically beplaced over a mass of tissue that the surgeon desires to suture. Theneedle 374 is reversible and configured to retract capsule 382 back in aproximal direction into the needle exit port of the proximal end portion376 of head 364.

FIG. 12C is a schematic view of needle 374 and the capsule 382 partiallyretracted into the proximal end portion 376 of head 364. The needle 374is retracted until the capsule 382 is parked inside the needle exit portof the proximal end portion 376 of head 364 and the suture 380 extendsacross the throat of head 364.

System 350 is suited for the intracorporeal suturing of tissue duringpelvic organ repair surgery, and in one embodiment is provided as asterile disposable surgical instrument that is discarded after thesurgical procedure. To this end, the components of system 350 areselected to be compatible with gas, steam, or radiation sterilization.

FIG. 13 is a perspective view of the introducer band 352. In oneembodiment, the introducer band 352 is a discontinuous band defined by afirst ring segment 390 separated from a second ring segment 392 by aspace 394 and includes a flange 396 that is configured to be removablyattached to the head 364 of delivery device 354 (FIG. 11). In oneembodiment, the first and second ring segments 390, 392 are curved todefine a substantially circular band sized to flexibly fit around afinger of a surgeon. The space 394 permits the ring segments 390, 392 toflex and adjust around differently sized fingers. The introducer band352 is adapted to be placed over a finger of the surgeon to direct thehead 364 of the delivery device 354 to a tissue landmark. The distal endof the finger of the surgeon is unencumbered and free to palpate tissueof the patient while the band 352 holds the delivery device 354 at theready for placement of suture 380 and capsule 382.

In one embodiment, the introducer band 352 is molded from plastic. Inone embodiment, the introducer band 352 includes a metal core (such asaluminum) having a plastic (such as silicone) molded over the metalcore.

FIG. 14 is a perspective view of another embodiment of an introducerband 402. FIG. 14 is oriented such that the view is directed to the padP of the finger F, and an outside surface of the index finger F isoriented in the up direction. That is to say, FIG. 14 is a depiction ofa pad of a left hand index finger.

In one embodiment, the introducer band 402 includes a base 404, a firstpair of arms 406 that are configured to wrap a portion of the way aroundthe finger F, a single arm 408 that is configured to wrap a portion ofthe way around the finger F in a direction opposite the first pair ofarms 406, and a metal interface 410 attached to the base 404. In oneembodiment, the metal interface 410 is a ferrous metal that isconfigured to magnetically couple with a magnet that is provided insideof the head 364 of the delivery device 354 (FIG. 11).

The introducer band 402 is malleable and configured to conform around afinger of the surgeon. In one example, the introducer band 402 isfabricated from a malleable sheet of metal that is over molded with aplastic coating, such as a core of 3003 series aluminum that is overmolded with silicone.

When the introducer band 402 is donned, the pad P of the finger F isexposed and available for palpating tissue to locate a desired landmarkwithin a patient. Thereafter, the surgeon magnetically attaches the head364 of the delivery device 354 (FIG. 11) to the metal interface 410 ofthe introducer band 402, and using the finger F, digitally delivers thehead 364 to the landmark.

FIG. 15 is a perspective view of another embodiment of an introducerband 422 attached to the head 364 of the delivery device 354 (FIG. 11).In one embodiment, the introducer band 422 includes a belt 424 having abuckle end 426, a free end 428, and a buckle 430 configured toselectively engage the free end 428 of the belt 424. In one embodiment,an exterior surface 432 of the belt 424 includes engagement recesses 434that allow the buckle 430 to adjustably engage the belt 424 around afinger of the user. In one embodiment, the belt 424 is fabricated fromplastic and the buckle 430 moves about a pin 436.

During use, the surgeon will use a finger to palpate a desired landmarkwithin a patient prior to donning the introducer band 422. Thereafter,the band 422 is attached to the finger to allow the finger to guide thehead 364 of the delivery device 354 (FIG. 11) directly to the identifiedlandmark. In one embodiment, the introducer band 422 is attached to thesurgeon's finger and the surgeon subsequently uses the finger to palpatea desired landmark within a patient.

FIG. 16 is a perspective view of another embodiment of an introducerband 442 attached to the head 364 of the delivery device 354 (FIG. 11).In one embodiment, the introducer band 442 includes a shell 444 that issized to receive the head 364 and a belt 446 that slides between twoopposed flanges 448, 450 to form a finger slot 451. In one embodiment, abelt stop 452 is provided that includes a post 454 that slides within anangled slot 456 to allow the selective adjustment of the belt 446 aroundthe finger F. The belt stop 452 is configured to prevent the band 446from sliding through the flange 450, which would undesirably result inthe finger slot 451 expanding after it is had been sized to fit aroundthe finger of the surgeon.

FIG. 17 is a perspective view of another embodiment of an introducerband 462 attached to the head 364 of the delivery device 354 (FIG. 11).In one embodiment, the introducer band 462 is integral with the head364. An adjustable finger slot 463 is provided by a belt 464 that isformed to extend from a base of the delivery head 364 and terminate atan adjustable engagement slide 466. In one embodiment, the belt 464includes a pressure platform 468 that allows the belt 464 to be adjustedby movement of one end 470 of the belt 464 relative to the engagementslide 466. In one embodiment, the engagement slide 466 is provided witha saw tooth pattern that is configured to mesh with saw teeth providedon the end 470 of the belt 464 to provide an adjustable and removablelocking mechanism. Alternatively, the engagement slide 466 is providedwith a hook-and-loop form of adjustable attachment. In one embodiment,the introducer band 462 is integrally formed as a complement of thedelivery head 364.

Embodiments of digital suture fixation systems have been described thatinclude a digital introducer that is attachable to a finger to guide ananchor delivery device intracorporeally to a patient. The introducer isattachable to the finger in one of a variety of approaches, includeattachment bands, magnetic attachment mechanisms, finger cots,attachment strands such as zip tie style strands, etc. The introducer isconfigured to allow the finger to palpate and identify a landmark withina patient and the delivery device is configured to insert an anchor or asuture attached to an anchor or capsule into the landmark. Thus,accurate placement of the anchor/suture is provided even if the landmarkis not visible to the surgeon.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. A method of fixing a suture to tissue of a patient, the methodcomprising: placing an introducer onto a finger, the introducerincluding a zip line trailing from a proximal end of the introducer;identifying a landmark with the finger; guiding a delivery device alongthe zip line toward the introducer, the delivery device maintaining ananchor attached to a suture line; and ejecting the anchor from thedelivery device and into the tissue of the patient.
 2. The method ofclaim 1, further comprising: pulling a portion of the suture line to alocation outside of the patient.
 3. The method of claim 2, furthercomprising: delivering support material into the patient's body alongthe suture line.
 4. The method of claim 3, further comprising: ejectingthe anchor from the delivery device through the support material andinto the tissue of the patient.
 5. The method of claim 1, whereinguiding a delivery device along the zip line toward the introducercomprises coupling a delivery device to the zip line outside of thepatient's body, guiding the delivery device along the zip line, andsecuring the delivery device to the introducer.
 6. The method of claim1, wherein the introducer defines a window sized to receive a pad of thefinger, and identifying a landmark with the finger comprises touching alandmark with the pad of the finger disposed in the window.
 7. Themethod of claim 1, comprising placing an introducer onto a finger offirst hand and ejecting the anchor from the delivery device and into thetissue of the patient with a second hand.
 8. A method of fixing a sutureto tissue of a patient, the method comprising: placing an introduceronto a finger; identifying a landmark with the finger; telescoping adelivery device from the finger to the tissue of the patient; andejecting the anchor from the delivery device and into the tissue of thepatient.
 9. The method of claim 8, wherein placing an introducer onto afinger comprises placing a delivery device attached to an introduceronto a finger.
 10. The method of claim 8, wherein telescoping a deliverydevice from the finger to the tissue of the patient comprises: attachinga shaft to a proximal end of the delivery device; pushing the shaftdistally; and axially expanding separating segments of a telescopingdelivery device.
 11. A method of fixing a suture to tissue of a patient,the method comprising: placing a delivery device attached to anintroducer onto a finger; identifying a landmark with the finger;pushing a needle through the tissue; capturing a capsule with theneedle, a suture line attached to the capsule; pulling the needle andthe capsule and the suture line through the tissue.
 12. The method ofclaim 11, wherein the introducer comprises a ring attachable to thedelivery device, the ring attachable around the finger.
 13. The methodof claim 12, wherein the ring is magnetically attachable to the deliverydevice.
 14. The method of claim 12, wherein the ring is adjustablyattachable around the finger.